Month: April 2023
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Risk assessment and management
Risk assessment Risk management process in pharma: Adapting the Risk assessment Risk management procedure in a pharmaceutical manufacturing firm is the process towards compliance of FDA guidelines issued by US FDA, accepting the existence of a risk is not bad but not making any remedial strategy to reduce the effects of risk, not making the…
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Successful USFDA Audit
Successful USFDA Audit. To understand how to do successful USFDA audit we must is understand why pharmaceutical companies are not able to cope up with the expectations of USFDA and land into the serious 483 observations. For successful USFDA audit. Following are the key points that a pharmaceutical manufacturing company is required to adapt so…
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Aseptic process sterile dosage form
What is Aseptic process sterile dosage form? The parenteral dosage form is required to be sterile and free from viable and non-viable microorganisms’ bacterial contamination as well as viral contamination. Aseptic process sterile dosage form manufacturing involves filling of sterile drug in to sterile containers and closures, inside a sterile environment clean room. Since the…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 